Clinical Research Coordinator III
11 days ago
Houston
Job DescriptionSalary: Commensurate with experience Clinical Research Coordinator III Location: Houston, Texas (Full-Time, On-Site) Department: Clinical Operations Reports To: Site Director / VP of Clinical Operations & Site Enablement About Axsendo Clinical Research Axsendo Clinical Research is a rapidly expanding, multi-market clinical research network supporting studies in Pain Management, Pulmonary Medicine, Cardiovascular Disease, Wound Care, Neurology, Metabolic Disease, and Medical Devices. Our Houston site is a high-priority location with a strong pipeline of complex and specialty trials. We are seeking an experienced Clinical Research Coordinator III to lead advanced study execution, mentor junior staff, and support high-quality enrollment and patient care across our therapeutic focus areas. Position Overview The Clinical Research Coordinator III (CRC III) is a senior-level role responsible for independently managing complex clinical trials with an emphasis on pain management, respiratory/pulmonary studies, cardiovascular research, and wound care protocols. The CRC III executes high-acuity visits, ensures exceptional documentation standards, supports investigators, and serves as a lead coordinator for challenging or high-volume studies. This role also provides mentorship, quality oversight, and leadership support to the entire Houston site. Key Responsibilities Advanced Study Execution Independently conduct complex and high-acuity study visits, including consenting, advanced assessments, sample handling, EKGs, respiratory testing, wound evaluations, pain scoring instruments, and device-related procedures Serve as the lead coordinator for pain management, pulmonary, cardiovascular, and wound care trials, ensuring deep protocol familiarity and operational readiness Conduct thorough prescreening, EMR review, and eligibility assessments for specialty studies Anticipate visit requirements and prevent deviations or out-of-window procedures Lead study startup tasks including source development, workflow planning, and protocol-specific staff training Data Integrity & Documentation Leadership Maintain audit-ready, ALCOA-compliant source documentation for all assigned studies Oversee data entry accuracy and supervise query resolution across complex protocols Identify data quality issues and collaborate with site leadership to implement corrective actions Support adverse event/serious adverse event documentation and reporting in high-risk therapeutic areas Sponsor, CRO, and Monitor Engagement Act as the primary site contact for IMVs, SQVs, SIVs, and COVs for specialty trials Prepare advanced study documentation and ensure timely follow-up on monitor findings Communicate proactively with sponsors, CROs, and clinical project teams regarding enrollment progress, data queries, and operational challenges Mentorship & Internal Leadership Provide day-to-day support, training, and workflow guidance to CRC I and CRC II team members Review junior staff documentation for completeness, GCP alignment, and accuracy Support the Site Director in promoting consistency, quality, and compliance across the Houston location Assist with onboarding new coordinators and supporting the development of SOPs, checklists, and best practices Operational & Clinical Collaboration Work closely with Principal Investigators and Sub-Investigators to ensure high-quality patient care and protocol adherence Partner with clinic administration to prepare rooms, equipment, and resources for specialty visits (respiratory tests, wound evaluations, cardiovascular assessments, pain-related procedures) Support high-volume clinic days and troubleshoot operational issues as they arise Regulatory, Safety & GCP Compliance Ensure strict adherence to ICH-GCP, FDA regulations, and internal SOPs Accurately document and escalate AEs/SAEs, particularly in high-risk indications Assist in preparing documentation for audits, site inspections, and quality reviews Support tracking of protocol deviations, CAPAs, and quality performance indicators Qualifications Required Minimum 35 years of direct clinical research experience, including complex and high-acuity trials Prior hands-on experience in pain management, pulmonary/respiratory studies, cardiovascular trials, or wound care research Ability to independently execute all study visit procedures and manage multiple protocols simultaneously Strong comprehension of ICH-GCP, regulatory expectations, and clinical operations workflows Experience engaging with monitors and supporting all types of monitoring visits Strong documentation skills with excellent attention to detail High emotional intelligence and strong patient communication skills Proven ability to mentor junior coordinators and support site-wide operational consistency Preferred Phlebotomy and EKG experience Experience with respiratory testing, wound assessments, or pain scoring tools Medical credential (CMA, EMT, LVN, RN) preferred but not required Bilingual (Spanish/English) highly valuable in Houston market Why Join Axsendo Senior clinical role supporting some of Houstons most impactful therapeutic studies Opportunity to lead complex trials in pain, respiratory, cardiovascular, and wound care Growth pathway into Lead Coordinator, Site Director, or Regional Operations roles Supportive leadership and a culture focused on service, integrity, and operational excellence Access to new studies, advanced training, and continuing education opportunities Compensation Competitive compensation commensurate with experience, plus benefits after eligibility period.